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Background

Over time, degenerative changes in the cervical spine lead to painful nerve entrapments which result in a condition called cervical radiculopathy.  Pinched nerves in the neck cause pain, weakness, and numbness that move down the arm.  Providence Medical Technology develops spinal therapies to help treat cervical radiculopathy.  The specific technology in the DTRAX implant is based on a design which involves minimal modification or stress to the natural spinal anatomy. The DTRAX implant delivery system is designed to be minimally invasive, to aid in fast recovery and minimize trauma to the patient.  Speck Design partnered with Providence Medical Technology from initial concepts to clinical device release of the DTRAX system.

As a growing company, Providence Medical Technology’s goal was to partner with experts in several areas: design, engineering, regulatory compliance, manufacturing, and production.  Speck Design was chosen to be a key partner in the device development process, involved in every aspect of the areas identified above.

Challenge

Providence Medical Technology sought to develop the original design concept of the delivery tools and implantable device for its DTRAX system, with its patients’ best interests in mind.

Speck Design was challenged to:
• Meet aggressive deadlines, despite the challenges of developing an implantable medical device and developing an original procedure workflow and associated tools.
• Work closely with Providence Medical Technology to provide functional designs accommodating the infinite variations of human anatomy while ensuring that the device was safe.
• Mentor a company through the medical device development process.

Solution

Our team, involved from Phase 0, was able to deliver on the aggressive deadlines, allowing Providence Medical Technology to go into OUS clinical device trials in a very short time period.  Providence Medical Technology’s clinical experience combined with Speck Design’s thorough and rigorous design and engineering processes allowed the successful release of the DTRAX system. 

Providence Medical Technology and Speck Design partnered from the very beginning of the development cycle, which made the research and design process dynamic, exhilarating and inspiring.  Speck Design’s ability to lead risk analysis efforts, set up initial regulatory documentation, and provide a roadmap for product development enabled Providence Medical Technology to better understand the process, and thus ensured a strong working relationship and quick, effective execution on project deliverables.

Speck Design’s ID and ME teams contributed to the understanding of usability and ergonomics of the delivery tool, and determined the design of the implant.  The close collaboration of the ID and ME talents was very effective in this project helping to quickly determine the design paths and execute various concepts to test the designs with Providence Medical Technology. Project milestones included designing a concept, building the prototype, and testing.  Throughout the process, Speck Design received immediate external feedback from surgeons on how to improve the design.  This information led to user-centric and procedure-compliant concepts of both the implantable device and the series of tools that are used for the implant process.

Results

After several iterations, the resulting system design was elegant and simple while still focusing on the most important factors: effective procedure, patient comfort and recovery. 

For the implant, Speck Design designed a very simple assembly that utilized both known mechanical design principles and innovative concepts, resulting in a device that met all the product requirements and effectively alleviated the nerve compression at the cervical spine.

For the implant deployment system Speck Design produced a series of tools based on earlier research and feedback to position and deploy the implant, continuously verifying the design against the system requirements and user feedback. 

The result was the DTRAX system that is inserted into a cervical facet joint in the patient’s spine through a one centimeter incision in the skin. The system allows all the surgical steps to be conducted through the single incision, by switching out various custom tools to perform each step of the procedure.  After the insertion and deployment of the implant, a bone graft is applied to promote bone growth and eventual fusion of the joint.

We helped advance Providence Medical Technology’s product strategy and helped them to become a viable business.  The approach to the partnership allowed us to provide Providence Medical Technology with exactly what they needed – a medical device development process experience, experienced ME and ID teams, and our network of manufacturers and material vendors.  Due to our device design efforts, Providence Medical Technology has applied for a series of patents for the DTRAX implantable device and system.

PROJECT INFO

• Client:

  Providence Medical Technology

• Project:

  Spinal Implant and Delivery System

• Industry:

  Medical